Cyberonics (Houston) on Friday issued a statement saying that it is going into a Securities and Exchange Commission-mandated “quiet period” as it enters the home stretch and heads for what it hopes will be final approval of its vagus nerve stimulation (VNS) system to treat treatment-resistant depression (TRD).
The statement said that it was informed by the FDA’s Center for Devices and Radiological Health that the center “was nearing completion of its final review of the conditions of TRD approval . . . outlined in a February approvable letter, and that the CDRH had requested that the Dallas District Office conduct a follow-up facility inspection.”
The inspection, it said “is to confirm the QSR [Quality System Regulations] corrective and preventive actions” put in place by the company in response to a warning letter from the agency’s Dallas office.
The company said that it was notified that the inspection and warning letter “were officially closed” as it had been notified – “verbally communicated,” it said – in April.
Contacted by Medical Device Daily on Friday, Cummins referred to the quiet period and said he had “no comment” beyond the company press release.
But he then did comment briefly, telling MDD that he believes the follow-on facility inspection is technically unnecessary but that the company was “looking forward” to completing and assisting with it “to make sure that we dot every ‘i’ and cross every ‘t.’” This should assure, he added, that a final agency decision would be “beyond re-proach.”
Cyberonics – and perhaps the device/med-tech arena in general – is clearly holding its breath concerning that final agency decision concerning the company’s system for treating TRD, since the regulatory road has been long and winding, especially featuring unexpected agency turns and twists that have puzzled the industry.
The agency made the unusual, but not unheard-of, decision to overrule a panel recommendation to approve the TRD application, and then reversed itself with the issuance of an approvable letter (MDD, June 17, 2004/Aug. 13, 2004/Feb. 4, 2005).
More recently, the company received a letter from the Senate Finance Committee, concerning the company’s regulatory odyssey.
In response to investor inquiries about the letter and a Wall Street Journal article reporting the letter, the company then issued statements verifying its receipt, but with Cummins emphasizing that the enquiry was focused on the FDA’s decision processes (MDD, May 20, 2005).
He charged that a “leak” to the Journal by an unidentified source was an attempt to slow final approval and commercial rollout of the system for TRD, but that it would have no such effect.
In last week’s statement, Cyberonics also said that the first four manuscripts from the pilot and pivotal studies of the TRD treatment have been accepted for publication “in respected psychiatric peer-reviewed psychiatry journals.” It added, though, that the journals and the authors of the articles won’t be disclosed until actual publication.
“Peer-reviewed journal publications of the most important results from the VNS TRD studies that are also presented in the labeling will accelerate VNS awareness and acceptance by psychiatrists, patients, families and payers,” Cummins said.
The manuscripts will cover, Cyberonics said, “the D-02 pivotal study acute results, the D-02 pivotal study one-year longitudinal results, the D-02 pivotal study one-year outcomes compared to those from the D-04 active treatment-as-usual control group and the D-01 pilot study two-year results.”
As to the follow-up inspections by the FDA, Cummins said that they will “confirm that Cyberonics has implemented all the corrective and preventive actions anticipated by our warning letter response and documented in the two status reports already provided to the Dallas District Office.”
As an overview statement, he said: “Cyberonics is looking forward to improving the lives of Americans touched by TRD with the same VNS Therapy that will very soon reach 100,000 patient years of U.S. epilepsy commercial experience.” The company received FDA approval of the epilepsy application in 1997.
According to the FDA’s “approvable” letter, final approval is conditional on final labeling, final protocols for a post-approval dosing optimization study and patient registry, satisfactory compliance with the QSR and satisfactory resolution of any outstanding bioresearch monitoring issues.
While awaiting the inspection and making what it called “minor” labeling changes requested by CDRH, the company’s “300-plus demand creation and customer support personnel,” Cummins promised, “will hone their skills by creating awareness, acceptance and demand for VNS Therapy among neurologists, surgeons, hospitals, payers and patients in epilepsy.”